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Drug Printing: Quality and Standards Lessons for Additive Manufacturing

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In-pharmacy 3D drug printing makes patient customization possible, including dose levels, combination polypills, allergen-free, flavored, and easy-to-swallow versions. Adoption hinges on reliability, repeatability, and quality. While in the US the governing regulations for special compounding for a single patient are relatively lenient, the spread of in-pharmacy 3D printing will require buy-in from prescribers, pharmacy owners, patients, and, optimally, producers of branded pharmaceuticals, so that their drugs can be personalized as needed. Qualification and certification adapt to the needs of small, personalized print runs, with a clear preference for non-destructive evaluation. In NIST-funded work leveraging FabRx’s M3DIMAKER printer, we introduced spectroscopic quality management. Pocket-sized near-infrared spectrometers can measure a range of factors as each dose is produced, including validating ingredient distribution. Setting up a quality framework suitable for in- pharmacy 3D printing uncovered important lessons that highlight links to cyberphysical security across additive manufacturing. To gain the confidence of drug producers (for licensed products) as well as doctors, patients, and pharmacists, the process must show resistance to sabotage, counterfeiting, and shortcuts. Areas needing monitoring include printers (who made them, who set them up or moved them, data security, layered access control), materials, and rights, but also the physical environment (process parameters such as temperature and humidity, as well as dust, cross-contamination, and cleaning), and print parameters that could – for economic gain – sabotage product quality and safety.

Pharmaceutical standards (including international quality guidance ICH Q10 and US FDA’s Chemistry, Manufacturing, and Controls approach) can be adapted, including traceability and data access requirements such as US 21CFR11. Existing pharmaceutical quality tests for particle size and distribution, including across layers, were found to be surprisingly well aligned with additive concerns. Key concepts include the wisdom of establishing verifiable analytical comparability, i.e. testing to match a standard, rather than relying on chains of assurances.

Learning Objectives:

  • Define quality and safety issues applicable to in-pharmacy 3D drug
  • Describe how spectroscopy can be applied for non-destructive evaluation and quality
  • List cyberphysical security parameters applicable across pharmaceutical and non- pharmaceutical additive manufacturing applications, and describe how they align with qualitative or quantitative measures of quality.